Fiscal period ending 2025-12-31 versus 2024-12-31
— view filing on EDGAR →
Government drug pricing controls under OBBBA — hitting Pomalyst, Orencia, and Eliquis — combined with accelerated biosimilar pathways and newly quantified tariff exposure represent a broad, concurrent tightening of the revenue and cost envelope. The pricing and biosimilar pressures are particularly acute: they directly compress margins on key franchises while simultaneously lowering the barrier for generic/biosimilar substitution. Tariff relief expiring in January 2029 adds a hard-dated supply-chain risk that management has acknowledged as potentially material.
3 company-specific
Company-specific changes
Revised
New government pricing agreements and OBBBA enacted; Pomalyst and Orencia now subject to price controls; free Eliquis to Medicaid materially worsens revenue outlook.
Product, Industry and Operational Risks Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins. Our products continue…
Revised
FDA issued new draft guidance in October 2025 accelerating biosimilar development and minimizing comparative clinical efficacy studies, materially increasing biosimilar competition risk.
We could lose market exclusivity of a product earlier than expected. In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is realized during…
Revised
Added specific tariff risk with quantified timeline (tariff relief until Jan 2029) and acknowledgment of potential material impact on business and results of operations.
We could experience difficulties, delays and disruptions in our supply chain as well as in the manufacturing, distribution and sale of our products. Our product supply and related patient access has…